Drugs on the market today are thoroughly tested with regard to their efficacy and safety during extensive clinical trials before they are approved for marketing by a national or regional Medical Products Agency, such as EMA in Europe or FDA in the U.S.
An important aspect of the clinical trials is to achieve an optimal dosage and administration regimen and these aspects are strictly controlled and monitored during the trials. During clinical trials the manufacturers of a drug collect a large amount of data on the drug. However, once the drug is on the market the control of the dosage is in many cases left to the patient undergoing therapy. This may lead to difficulties in individualizing the used dosage of pharmaceutical products to patient specific conditions and lack of compliance to the prescribed dosing, such as under-dosage, over-dosage and gaps in the administration regimen, which leads to unsatisfactory therapeutic results of the treatment.
Drugs on the market today are stand alone products without any support or connection to the vast amount of data generated during the research and development phase of the product, which could be used for simplifying and optimizing the relation between patient needs and pharmaceutical product clinical conditions. The guidance for matching patient specific conditions to the use of pharmaceutical products is limited.
One of the major issues to reach an increased clinical effect of pharmaceutical treatments in clinical practice is to improve adherence to prescribed medication, see World Health Organisation 2003 Report: Adherence to long-term therapies; Evidence for action: whqlibdoc.who.int/publications/2003/9241545992.pdf
Due to the lack of adherence to medication the results of pharmaceutical treatments in clinical practice have difficulties in reaching the same results in clinical effect as the ones made in clinical trials during the development of the pharmaceutical products.
In regulations from FDA and EMA focus on patient safety and follow-up of side effects, as well as possible adverse events, regarding pharmaceuticals is crucial. In clinical practice, however, this is difficult to achieve and a major responsibility is on the patient with little or no support to accomplish it properly.
Even though the safety concerns of medications are directly related to the specific pharmaceutical products, today there are very limited features, or no features, at all integrated with the pharmaceutical product aiming at improving the patient safety concerns of the product. The major responsibility for patient safety for specific pharmaceutical products is on the patients themselves.
Medical devices enhancing the therapeutic effect of drugs are known. For instance, specifically designed inhalers are used to administer various anti-asthmatic drugs and implantable devices have been used for controlled release of anti-cancer drugs.
Patient compliance and monitoring systems are known in the art, e.g. WO02095352. Such systems are focused on monitoring patient compliance and reporting to the medical practitioner and the patient how the treatment is progressing. The system disclosed in WO02095352 is relevant for a certain condition (menopause) and a general therapy (hormone replacement therapy). It is not specifically adapted for a certain pharmaceutical product.
Patient-reported outcome (PRO) measures are used in medical product development and sometimes used to support labelling claims, see U.S. Department of Health and Human Services Food and Drug Administration. Guidance for Industry. Patient-Reported Outcome Measures: use in Medical Product Development to Support Labelling Claims, 2009, www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf.
A further development of PRO:s is the concept of electronic PRO:s, ePRO:s, which nowadays are partly accepted within clinical practice. One example of such an ePRO is described in McCann et al, European Journal of Cancer Care, 18, 156-164. The system described by McCann et al is however adapted to a chemotherapy in general and not integrated with a specific pharmaceutical product.